Abstract
A simple, rapid and robust reverse phase HPLC method was developed and validated for the determination of impurities in Dolutegravir drug substance. The main aim of this study is to reduce the time consumption and to develop and validate a less expensive method by using HPLC. The chromatographic separation of Dolutegravir and its related impurities is carried out by using C8 column (150 × 4.6 mm), 5µm with 0.1% trifluoroacetic acid in water as mobile phase A, methanol as mobile phase B. The flow rate is 1.0 mL/min with gradient elution mode and the wave length for detection is 240 nm (UV detector). The developed method was validated and proved that the method was specific, accurate and precise as per ICH. The system suitability criteria found to be within the limits. The limit of detection and limit of quantification demonstrate that the method is sensitive. The linearity curve was found to be linear and the correlation coefficient obtained is not less than 0.998. The average percentage recoveries of impurities were in the range of 97 to 101%. The proposed method was found to be suitable and accurate for quantitative determination of impurities in Dolutegravir drug substance.
Highlights
Dolutegravir belongs to a group of HIV drugs called ‘ integrase ’ inhibitors
The validation of HPLC method was carried out for the determination of Impurity-A, Impurity-B and Impurity-C in Dolutegravir drug substance as per the ICH guidelines to demonstrate that this method is stability indicative for intended use
System suitability: The system suitability was performed for every validation parameters by injecting of system suitability solution containing 0.5 mg/mL of Dolutegravir and 0.0005 mg/mL of each impurity
Summary
Dolutegravir belongs to a group of HIV drugs called ‘ integrase ’ inhibitors. Integrase inhibitors block HIV enzyme called integrase. Integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body. Dolutegravir is a prescription medicine approved by the U.S Food and Drug Administration (FDA) for the treatment of HIV infection in combination with Rilpivirine (brand name: Edurant). Dolutegravir (DTG), sold under the brand name Tivicay, is an antiretroviral medication, used together with other medication, to treat HIV/AIDS. It may be used, as part of post exposure prophylaxis, to prevent HIV infection following potential exposure [1,2,3].
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